# K221168: Tinnitogram Signal Generator

- Pathway: 510(k) (Traditional)
- Applicant: Goldenear Company, Inc.
- Decided: Feb 1, 2023 after 285 days
- Product code: KLW (Masker, Tinnitus)
- Device class: 2
- Regulation: 21 CFR 874.3400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K974501 (1998). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151719: REVE134, Kw Ear Lab, Inc. (2015) Summary page 4.

## Indications for use
Tinnitogram™ Signal Generator is a sound generating software used in a Tinnitus Management Program designed to provide temporary relief for people experiencing tinnitus symptoms. It is intended primarily for adults over 18 years of ages, but may also be used for children 5 years of age or older. Tinnitogram™ Signal Generator is for use by hearing healthcare professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. A hearing healthcare professional should recommend that patient listen to the Tinnitogram™ Signal Generator signal for 30 minutes twice a day at the barely audible level (minimally detectable level).

Source page: https://510kreport.com/device/K221168
Methodology: https://510kreport.com/methodology